This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients with stage IV melanoma receiving ipilimumab or pembrolizumab therapy. Diagnostic procedures, such as single-photon emission computed tomography (SPECT), uses radioactive drugs and a scanner to make detailed pictures of areas inside the body and may be a less invasive way to check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2, carry radiation directly to cancer cells and may be able to differentiate between tumor growth due to inflammation versus tumor progression in patients with stage IV melanoma receiving therapy.

Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30-45 days after study discontinuation ] [ Designated as safety issue: Yes ]

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

Spearman rank correlation coefficients will be used to examine the association between T/B ratio and the pre-treatment tumor biomarkers. Spearman rank correlation coefficients will be used to examine the association between changes in T/B ratio and the change in tumor burden, changes in TIL percentages, and changes in peripheral blood concentrations of T, B, and NK cell subsets.

After completion of study treatment, patients are followed up at 30-45 days.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Pathologic proof of stage IV melanoma (pathology report confirmation) with plans to initiate therapy with ipilimumab or MK-3475 according to Food and Drug Administration (FDA) approved guidelines (ipilimumab) or expanded access program (MK-3475) specifications, with multiple lesions such that

Two of these lesions are in the same organ and at least one of these two lesions is measurable by computed tomography (CT) imaging according to RECIST 1.1 OR

Three of these lesions are in different organs and at least one of these 3 lesions is measurable by CT imaging according to RECIST 1.1

Patient eligible for and will be receiving ipilimumab as standard of care therapy or MK-3475 (enrollment into MK-3475-030 expanded access program is required); Note: only patients eligible for MK-3475-030 would have access to MK-3475 and therefore be eligible for the current study

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789827